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510(k) K210444

Device
EZ-Injec LDV Sterile Safety Needle
Applicant
Poonglim Pharmatech Inc.
510(k) number
K210444
Product code
QNS  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-16
Date received
2021-02-16
Regulation
880.5570
Classification name
Low Dead Space Needle, Single Lumen, Hypodermic
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cho Hee Min
Address
21, Jayumuyeok 1-Gil Gunsan KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QNS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLC2024-10-25
K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK2024-03-08

Legacy Summary#

summary

FDA Review#

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